Classification guidelines for medical and non-medical robots
It might be interesting for many of us to look a little into the details of current medical robot categorization practices form the standardization point of view. (Excerpts from Gurvinder S. Virk, Tamás Haidegger: Classification Guidelines for Personal Care Robots Medical and non-medical applications.)
"Robotics is evolving from its traditional roots in industrial manufacturing towards the realization of a wide variety of service applications where the new robots are aimed at performing “useful tasks for humans or equipment excluding industrial automation applications”. Currently, specific regulations exist only for the industrial robots (which rely on separating the manufacturing robots from humans using real or virtual cages) and this is presenting a bottleneck for the development of the new service robot markets where the robots need to interact closely with humans. The key missing requirements here are the lack of suitable international safety requirements for the new service robot applications to allow the needed human-robot interactions including human-robot contact; this is causing difficulties for commercializing the new products due to the fear of crippling litigation actions in the event of accidents occurring.
Current standards and regulations put the focus on the intended use as defined by the manufacturer when dealing with the classification of a particular robot system. It is possible to consider the key issues from two perspectives, namely:
- physically assistive robots: such robots are used to provide physical support to users. Some examples to contrast the medical and non-medical applications are the following:
- Physical rehabilitation exoskeleton (medical) versus an assistive exoskeleton for soldiers in the field, or supporting exoskeletons for persons working in a manufacturing line or at home carrying heavy objects (personal care)
- Porter-type robot for logistics tasks in a hospital: its classification (medical or non-medical) depends on if it is involved in some part of a medical treatment. One example, in the case of medicine delivery, if there is human involvement (in the medicine delivery or decision making activities) after the robot has delivered its service then it is non-medical
- Scrub nurse robot: operating in a sterile environment of the operating theatre (medical) versus performing general tasks in open wards (non-medical)
- cognitive support robots: such robots are used to provide emotional and mental support to users. Examples include the following:
- Robots in psychology: if a medical treatment is provided (following a professional’s diagnosis), then the robot is a medical device and must be regulated as such
- Robot companions: for providing social support and companionship could be simple leisure time devices but users may get emotionally attached and there could be undesirable psychological side effects which need to be thought about
- mobile servant robots: some of these are designed for personal care to perform domestic tasks (non-medical), but some systems could involve a medical doctor “e-visiting” a patient through an avatar that is used to perform some diagnosis (e.g., by measuring blood pressure) and providing some treatment (ordering medication or injecting drugs), making them medical devices."